A clinical trial is a medical research study involving human subjects. Clinical trials are used to determine if a new medical drug (compound), medical device, or medical procedure is safe and effective for human use. Clinical trials are scheduled after successful pre-clinical animal testing. Clinical trials are burdened with expense and inefficiency in the recruitment of subjects. The average number of eligibility criteria used to screen volunteers has risen exponentially over the years, contributing to a decline in volunteers willing to enroll in the trials.
Additionally, the number of required procedures for each clinical trial has risen dramatically in the last several years. This is partly because of the increasing complexity of the studies themselves, and partly because of the mandated safeguards. The increased procedures dissuade volunteers from completing the trials. Because clinical trials involve experimental drugs and procedures, a host of safeguards has been set in place to protect the human subject as much as possible. The Department of Health and Human Services mandates policies to protect the confidentiality and rights of human trial subjects. Standards and guidelines are in place to ensure that the final results that are reported are accurate and credible and that the confidentiality and rights of trial participants are protected. While necessary, this adds a tremendous administrative overhead to an already expensive endeavor.
There is a need for a method to improve the efficiency while reducing the costs of clinical trials.